Chris Reid is CEO of Integrity. Chris started his career as an automation engineer, providing software solutions to the chemical and pharmaceutical industry. For the past 30+ years, Chris has provided IT program governance and IT quality solutions to global regulated companies. Chris is a former ISPE Board Member, ISPE GAMP Global Chair and currently holds positions on the ISPE Foundation Board and GAMP Global Steering Committee.
IT Infrastructure is a broad term that encompasses both the platforms upon which business applications run, as well as the services that keep these platforms and applications running. Figure 1 below shows this landscape.
This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality initiative1
1US Food and Drug Administration Center for Devices and Radiological Health. “Case for Quality.” 29 July 2020.